Left Atrial Appendage Closure Versus Direct Oral Anticoagulants
in High-Risk Patients With Atrial Fibrillation

J 2020

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

OSMANCIK, P., D. HERMAN, P. NEUZIL, P. HALA, M. TABORSKY et. al.

Basic information

Original name

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

Authors

OSMANCIK, P. (203 Czech Republic, guarantor), D. HERMAN (203 Czech Republic), P. NEUZIL (203 Czech Republic), P. HALA (203 Czech Republic), M. TABORSKY (203 Czech Republic), Petr KALA (203 Czech Republic, belonging to the institution), Martin POLOCZEK (203 Czech Republic, belonging to the institution), J. STASEK (203 Czech Republic), L. HAMAN (203 Czech Republic), M. BRANNY (203 Czech Republic), J. CHOVANCIK (203 Czech Republic), P. CERVINKA (203 Czech Republic), J. HOLY (203 Czech Republic), T. KOVARNIK (203 Czech Republic), D. ZEMANEK (203 Czech Republic), S. HAVRANEK (203 Czech Republic), V. VANCURA (203 Czech Republic), J. OPATRNY (203 Czech Republic), P. PEICHL (203 Czech Republic), P. TOUSEK (203 Czech Republic), V. LEKESOVA (203 Czech Republic), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution), Martina NOVÁČKOVÁ (203 Czech Republic, belonging to the institution), Klára BENEŠOVÁ (203 Czech Republic, belonging to the institution), P. WIDIMSKY (203 Czech Republic) and V. Y. REDDY (840 United States of America)

Edition

Journal of the American College of Cardiology, New York, Elsevier Science INC, 2020, 0735-1097

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 24.094

RIV identification code

RIV/00216224:14110/20:00116128

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.jacc.2020.04.067

UT WoS

000550518000004

Keywords in English

atrial fibrillation; cardioembolic event; direct oral anticoagulant; left atrial appendage; stroke

Abstract

V originále

BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA(2)DS(2)-VASc of >= 3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA(2)DS(2)-VASc: 4.7 +/- 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944) (C) 2020 by the American College of Cardiology Foundation.

Citovat

OSMANCIK, P., D. HERMAN, P. NEUZIL, P. HALA, M. TABORSKY, Petr KALA, Martin POLOCZEK, J. STASEK, L. HAMAN, M. BRANNY, J. CHOVANCIK, P. CERVINKA, J. HOLY, T. KOVARNIK, D. ZEMANEK, S. HAVRANEK, V. VANCURA, J. OPATRNY, P. PEICHL, P. TOUSEK, V. LEKESOVA, Jiří JARKOVSKÝ, Martina NOVÁČKOVÁ, Klára BENEŠOVÁ, P. WIDIMSKY and V. Y. REDDY. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. Journal of the American College of Cardiology. New York: Elsevier Science INC, 2020, vol. 75, No 25, p. 3122-3135. ISSN 0735-1097. Available from: https://dx.doi.org/10.1016/j.jacc.2020.04.067.

@article{1673138,
   author = {Osmancik, P. and Herman, D. and Neuzil, P. and Hala, P. and Taborsky, M. and Kala, Petr and Poloczek, Martin and Stasek, J. and Haman, L. and Branny, M. and Chovancik, J. and Cervinka, P. and Holy, J. and Kovarnik, T. and Zemanek, D. and Havranek, S. and Vancura, V. and Opatrny, J. and Peichl, P. and Tousek, P. and Lekesova, V. and Jarkovský, Jiří and Nováčková, Martina and Benešová, Klára and Widimsky, P. and Reddy, V. Y.},
   article_location = {New York},
   article_number = {25},
   doi = {http://dx.doi.org/10.1016/j.jacc.2020.04.067},
   keywords = {atrial fibrillation; cardioembolic event; direct oral anticoagulant; left atrial appendage; stroke},
   language = {eng},
   issn = {0735-1097},
   journal = {Journal of the American College of Cardiology},
   title = {Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation},
   url = {https://www.sciencedirect.com/science/article/pii/S0735109720351755?via%3Dihub},
   volume = {75},
   year = {2020}
}

TY  - JOUR
ID  - 1673138
AU  - Osmancik, P. - Herman, D. - Neuzil, P. - Hala, P. - Taborsky, M. - Kala, Petr - Poloczek, Martin - Stasek, J. - Haman, L. - Branny, M. - Chovancik, J. - Cervinka, P. - Holy, J. - Kovarnik, T. - Zemanek, D. - Havranek, S. - Vancura, V. - Opatrny, J. - Peichl, P. - Tousek, P. - Lekesova, V. - Jarkovský, Jiří - Nováčková, Martina - Benešová, Klára - Widimsky, P. - Reddy, V. Y.
PY  - 2020
TI  - Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation
JF  - Journal of the American College of Cardiology
VL  - 75
IS  - 25
SP  - 3122-3135
EP  - 3122-3135
PB  - Elsevier Science INC
SN  - 07351097
KW  - atrial fibrillation
KW  - cardioembolic event
KW  - direct oral anticoagulant
KW  - left atrial appendage
KW  - stroke
UR  - https://www.sciencedirect.com/science/article/pii/S0735109720351755?via%3Dihub
L2  - https://www.sciencedirect.com/science/article/pii/S0735109720351755?via%3Dihub
N2  - BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA(2)DS(2)-VASc of >= 3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA(2)DS(2)-VASc: 4.7 +/- 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944) (C) 2020 by the American College of Cardiology Foundation.
ER  -

OSMANCIK, P., D. HERMAN, P. NEUZIL, P. HALA, M. TABORSKY, Petr KALA, Martin POLOCZEK, J. STASEK, L. HAMAN, M. BRANNY, J. CHOVANCIK, P. CERVINKA, J. HOLY, T. KOVARNIK, D. ZEMANEK, S. HAVRANEK, V. VANCURA, J. OPATRNY, P. PEICHL, P. TOUSEK, V. LEKESOVA, Jiří JARKOVSKÝ, Martina NOVÁČKOVÁ, Klára BENEŠOVÁ, P. WIDIMSKY and V. Y. REDDY. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. \textit{Journal of the American College of Cardiology}. New York: Elsevier Science INC, 2020, vol.~75, No~25, p.~3122-3135. ISSN~0735-1097. Available from: https://dx.doi.org/10.1016/j.jacc.2020.04.067.

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